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NCT Number: NCT07645495

Frequency Rhythmic Electrical Modulated Stimulation Therapy in Chronic Ulcers.

The goal of the study is to

1. To measure wound size of chronic ulcers after using FREMS therapy and phenytoin application in the interventional group monthly till the end of the third month compared to baseline. 2. To measure wound size of chronic ulcers after using standard of care in control group monthly till the end of the third month compared to baseline. 3. To compare the results of the 2 groups and determine the significance of the treatment.

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Key information

Conditions

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

Wound ulcers including diabetic foot ulcers impose a substantial and escalating economic burden on healthcare systems worldwide. In the United States alone, chronic wounds affect over 10 million people and account for annual healthcare costs ranging from $28.1 to $96.8 billion. Major challenges persist, including antibiotic resistance, high recurrence rates, delayed healing in patients with comorbidities, and limited evidence for many advanced therapies. Additionally, cost, access to specialized care, and the need for individualized, multidisciplinary management remain significant barriers to optimal outcomes. Using two effective modalities in cases that are resistant to all known treatments, whether they are conservative or adjuvant, is a promising technique to end the entrapment of a wound in a certain stage and avoid complications like further amputation. enrolled patients will be randomly assigned to one of either groups Group A: Intervention group that will receive 3 sessions /week of FERM with phenytoin application with spraying phenytoin topical 40 mg spray after each session according to ulcer size to cover the ulcer.

Group B: Control group that will receive standard of care and will be assessed at baseline and every month till they completed 3 months of treatment.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • chronic ulcers more than 3 months.

Exclusion criteria

  • incapable of being in the clinic of diabetic ulcer during treatment period 3 days/ week for 3 months.
  • severe ischemia that is indicated for a surgery.
  • infection or osteomyelitis.

Treatment and study plan

FREMS

Device

frequency rhythmic electrical stimulation which is an electrical device specialized in diabetes complications like ulcers and neuropathies, with proven efficacy in neuropathies, and promising results in ulcers.

Primary outcomes

  1. healing rate

    Time frame: measuring once a month for 3 months.

    wound size

Study contacts

Contact information is provided by the study sponsor or research team.

Ibtihal Nassar, Msc.

CONTACT

[email protected]

+201151678506

Sponsors and collaborators

Lead sponsor

Beni-Suef University

Other

Collaborators

  • General Organization for Teaching Hospitals and Institutes

Registry information

Official study title

Chronic Ulcer Healing With Frequency Rhythmic Electrical Modulated Stimulation (FREMS)Therapy and Phenytoin Application in Diabetic Patients.

Acronym: FREMS

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jun 12, 2026
Registry last updated
Jun 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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